Multimodal Differences in Effort-based Decision-Making in Depression

NCT06648460 | Not Yet Recruiting

• 1 other identifier: H24306
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a serious condition that causes long-term symptoms such as feeling sad, losing interest in activities, and having thoughts of self-harm. Difficulty in making an effort is a key factor in functional impairment. Current methods to evaluate this difficulty use clinical assessments and computer-based tasks, but there is a gap between the measurements and real-life behavior. To address this, the study team proposes creating an instrumented behavioral test, HORMES, to objectively assess reduced motivation during everyday activities and measure physiological responses. The study will examine differences in brain activity, autonomic system function, and metabolic energy expenditure in patients with major depression during a decision-making task that involves physical effort.

Conditions

Depression; Anhedonia

Keywords

Effort-based decision-making; Physical Effort

Outcome Measures

Primary Outcomes (1)

• Time spent in high-effort "rooms"

  Participants will be measured on how much time they spend in "rooms" that require high effort in the form of walking on an inclined treadmill as a proportion of the total duration of the task. This measures the willingness of participants to engage in effortful behavior.

  1 day

Study Arms (1)

Effort-based decision-making

OTHER

Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards.

Other: Effort-based Decision-Making Task

Interventions

Effort-based Decision-Making Task OTHER

Virtual Reality-based multi-stage task in which individuals must explore distinct "rooms" in a virtual environment that vary in the amount of effort (walking) and reward (points) they receive.

Effort-based decision-making

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Matched control group
• years old
• Able-bodied
• Fluent in English
• Able to give written and verbal informed consent to the proposed experiment
• Able to comprehend the study procedure, potential risks, and benefits
• Group with depression
• Diagnosed with major depression
• Quick Inventory of Depression Symptomology (QIDS) score \> 5
• years old
• Able-bodied
• Fluent in English
• Able to give written and verbal informed consent to the proposed experiment
• Able to comprehend the study procedure, potential risks, and benefits

You may not qualify if:

• Matched control group
• Current diagnosed psychiatric disorder (e.g., anxiety, depression, bipolar disorder)
• Current pregnancy
• BMI \> 35
• Currently on antipsychotics
• Group with depression
• Diagnosed with psychotic symptoms
• Diagnosed with other neurological or psychiatric disorders
• Current pregnancy
• BMI \> 35
• Currently on antipsychotics

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• Emory University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Georgia Tech Manufacturing Institute

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher J Rozell, Ph.D.

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Rozell, Ph.D.

CONTACT

404-385-7671; crozell@gatech.edu

Sankaraleengam Alagapan, Ph.D.

CONTACT

sankar.alagapan@gatech.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study in which individuals with depression and matched controls will perform an effort-based decision-making task.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)